Amneal Pharmaceuticals has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for Propofol Injectable Emulsion USP, 200 mg/20 mL (10 mg/mL), 500 mg/50 mL (10 mg/mL), and 1,000 mg/100 mL (10 mg/mL), Single-Dose Vials.

Propofol is an intravenous drug commonly used in hospitals for the induction and maintenance of anesthesia and sedation. It is currently on the American Society of Health System Pharmacists (ASHP) drug shortages list.

Propofol has a history of shortage due to supply chain constraints. Amneal will manufacture the product in-house on a dedicated line to provide consistent supply. The company expects to launch propofol in the fourth quarter of 2024.

“Amneal is keenly focused on delivering critical drugs that are in short supply. This single dose formulation of propofol is an essential medicine utilized every day by hospitals for surgical use. We are proud to provide our hospital customers with this hard-to-make product and help patients in need. With our large global manufacturing footprint, Amneal aims to be the provider of choice for complex products like propofol,” said Andy Boyer, Executive Vice President, Chief Commercial Officer – Generics, Amneal.

Propofol is contraindicated in people who have known hypersensitivity to propofol, egg or soybean. According to IQVIA, U.S. annual sales for propofol for the 12 months ended June 2024 were approximately USD 314 million.